Senior Clinical Research Coordinator - 256936
Medix™
Must Haves: Minimum 3 years of experience as a CRC, previous dermatology or aesthetics experience required Hours: 40 hours per week, Monday-Friday onsite, normal business hours Contract Duration: contract-to-hire, 9 month contract then have the opportunity to be hired on permanently depending on performance Benefits Medical Dental Vision time off paid holidays off 401k growth opportunities etc. About the Role Position Summary The Clinical Research Coordinator (CRC) coordinates the day-to-day conduct of clinical studies with a focus on dermatology and aesthetic medicine. The CRC manages assigned studies from start-up through closeout, coordinates participant visits, maintains accurate source and regulatory documentation, enters and resolves study data, supports recruitment and retention, and serves as a primary operational contact for participants, investigators, monitors, sponsors, and CROs. The successful candidate combines strong clinical research fundamentals with practical knowledge of dermatologic conditions, aesthetic treatments, skin assessments, photography, and participant care. Essential Duties and Responsibilities Study Coordination and Visit Management Coordinate assigned studies from site activation through closeout in accordance with the protocol, Good Clinical Practice (GCP), company SOPs, and sponsor requirements. Review protocols, manuals, schedules of activities, informed consent forms, case report forms, and study systems; translate requirements into organized visit workflows and study tools. Schedule and conduct study visits, coordinate investigator and evaluator availability, confirm visit readiness, and ensure required procedures occur within protocol windows. Perform protocol-permitted coordinator procedures after documented training and competency, which may include vital signs, medical and medication history, adverse-event review, questionnaires, sample collection or processing, ECG support, and device or imaging workflows. Track participant visits, outstanding procedures, laboratory results, safety follow-up, deviations, action items, and study milestones; escalade concerns promptly. Dermatology and Aesthetic Research Responsibilities Support studies involving medical dermatology, skin quality, injectables, neurotoxins, fillers, biostimulators, energy-based devices, hair and scalp conditions, topical products, and other dermatologic or aesthetic indications. Demonstrate familiarity with common dermatologic terminology, lesion and skin-condition documentation, treatment areas, Fitzpatrick skin types, cosmetic treatment history, and relevant concomitant medications. Coordinate standardized clinical photography and imaging, including participant positioning, lighting, camera settings, image labeling, privacy protections, and sponsor-specific image-transfer requirements. Support investigator, blinded evaluator, and participant-reported assessments while protecting blinding and preventing influence or coaching. Prepare treatment rooms and study supplies, support investigational product or device accountability as assigned, and maintain separation of blinded and unblinded activities when required. Recognize and promptly elevate potential adverse events, unanticipated reactions, worsening skin conditions, infection concerns, or other participant-safety issues to the investigator. Participant Recruitment and Retention Conduct protocol- and IRB-approved prescreening, communicate study expectations clearly, and schedule potentially eligible participants efficiently. Support informed consent discussions without coercion, confirm that consent is completed before study procedures, and document the process accurately. Build professional, responsive relationships with participants while maintaining appropriate boundaries, privacy, and confidentiality. Track recruitment funnels, screen failures, enrollment, retention, missed visits, and participant follow-up; communicate barriers and proposed solutions to site leadership. Use only approved recruitment materials, scripts, prescreening tools, and communication methods. Data, Source Documentation, and Regulatory Compliance Create and maintain clear, contemporaneous, accurate, complete, and attributable source documentation consistent with ALCOA+ principles. Enter study data into EDC and other sponsor systems within required timelines; resolve queries accurately and promptly. Maintain study files and essential documents, including training, delegation, screening and enrollment logs, communications, safety documentation, and visit records. Identify and document protocol deviations, safety events, consent issues, and data discrepancies; support root-cause review and corrective and preventive actions. Protect participant confidentiality and comply with HIPAA, FDA regulations, IRB requirements, ICH guidelines, the protocol, and company SOPs. Monitoring, Audit, and Sponsor Support Prepare for and participate in site initiation, monitoring, closeout, audit, and inspection activities. Provide monitors with organized access to source, regulatory, data, pharmacy or product, and facility records appropriate to their role and authorization. Respond to monitoring findings and follow-up items within assigned timelines; communicate risks or delays to the Clinical Site Manager. Maintain professional, timely communication with sponsors, CROs, central vendors, laboratories, imaging providers, and other study partners. Team and Site Responsibilities Collaborate with investigators, evaluators, research assistants, fellow coordinators, front-office staff, and site leadership to ensure safe and efficient study conduct. Maintain study rooms, supplies, equipment, temperature logs, specimen-processing areas, and other assigned site functions in inspection-ready condition. Participate in protocol training, site meetings, cross-training, quality reviews, recruitment planning, and process-improvement initiatives. Manage competing priorities independently, ask for assistance before timelines or quality are affected, and provide reliable coverage for the research team. Required Qualifications At least two years of clinical research coordinator experience managing interventional studies; direct experience in dermatology and/or aesthetic clinical research is required. Working knowledge of GCP, ICH guidelines, FDA regulations, IRB requirements, HIPAA, informed consent, source documentation, adverse-event reporting, protocol deviations, and data-query resolution. Experience coordinating participant visits, entering data in EDC, maintaining regulatory documentation, and supporting sponsor monitoring visits. Practical familiarity with dermatologic and aesthetic terminology, skin assessments, standardized clinical photography or imaging, and common treatment or procedure workflows. Strong organizational, documentation, communication, prioritization, and problem-solving skills with close attention to detail. Ability to work professionally with participants, investigators, monitors, sponsors, vendors, and coworkers while handling confidential information appropriately. Proficiency with Microsoft 365 and common clinical research systems, such as EDC, CTMS, eReg/eISF, ePRO, IRT, imaging portals, and sponsor platforms. Current GCP and human-subject-protection training, or ability to complete required training before independently performing study duties. Preferred Qualifications Bachelor's degree in life sciences, nursing, public health, psychology, or a related field preferred ACRP or SOCRA certification, such as CCRC or CCRP preferred Experience with medical dermatology indications, cosmetic injectables, energy-based devices, hair or scalp studies, topical products, or aesthetic imaging. Experience working on blinded studies, device studies, photography-based endpoints, central image review, or investigator rating scales. Experience processing and shipping biological specimens and working with central laboratories. Bilingual English/Spanish communication skills. #J-18808-Ljbffr Medix™
$80k - $90k
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